Pfizer never listed N-nitrosodimethylamine, or NDMA, a human carcinogen, as an ingredient in Zantac, the lawsuit alleges.
Since September, numerous recalls have been issued for ranitidine products, the generic name for Zantac, after the FDA found unacceptable levels of NDMA in some ranitidine products.
“While defendant represented that its Zantac formulation was safe for use, Zantac contains dangerously high levels of NDMA, rendering the product dangerous and unfit for human consumption,” the lawsuit says, according to the New York Law Journal.
The lawsuit was filed on behalf of Dana Viola, a New Jersey resident who took Zantac from 2000 to 2016 and stopped when several drugmakers began recalling the drug, according to the New York Law Journal.
The lawsuit alleges breaches of warranty, unjust enrichment, fraud, fraudulent concealment and violations of the New Jersey Consumer Fraud Act. It seeks compensatory, statutory and punitive damages, as well as restitution and attorney fees, according to the New York Law Journal.
“Plaintiff is further entitled to statutory damages, damages for the injury sustained in consuming high levels of acutely-toxic NDMA, and for damages related to defendant’s conduct,” the lawsuit reportedly said.
In a statement to the New York Law Journal, Pfizer said it has not sold Zantac in 13 years.
“We believe this proposed class-action complaint is without merit and will respond to it in due course,” the company stated.
Read the full article here.
More articles on pharmacy:
How 503B outsourcing can reduce hospital pharmacies’ regulatory burden — 5 Qs with QuVa Pharma CEO Stuart Hinchen
Illumina abandons $1.2B PacBio acquisition
FDA rush to meet drug approval deadlines doubles adverse patient effects, study finds
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.